Nation of Pill Poppers: 19 Potentially Dangerous Drugs Pushed By Big Pharma
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Original safety trials were also marred with major fraud.
Pharma doctors, when reviewing the study results at FDA hearings in 2005 and 2008, blamed LABA deaths on patients' underlying disease and non-compliance and dismissed hospitalization as a side effect less serious than death. They danced around FDA testimony, including from Dr David Graham of Vioxx fame, that there is no scientific evidence that the inhaled corticosteriods found in Advair and Symbicort make the products safer and that LABA's modest clinical benefit does not justify their 28-fold increase in mortality risks. (5,000 deaths in ten years estimated Graham.)
While many regard LABAs as a medical mishap, marketing for "step up" asthma treatment is no misttake. Though inhaled corticosteriods are still considered the best asthma treatment, millions have been convinced they need two drugs to control their asthma and that the combination is keeping them out of hospitals. Except when it isn't.
Singulair and Accolate, leukotriene receptor antagonists
How did Merck convince Americans to use an allergy drug that works no better than over-the-counter antihistamines but costs eight times as much?
A drug in which "asthma control deteriorates when switched from low dose inhaled corticosteriods" according to original FDA reviewers in 1998 -- but was approved anyway?
How did Merck convince pediatricians and mothers to give kids such a drug on a daily basis for seasonal allergies, runny noses and minor wheezing? Even though FDA reviewers cautioned that adult trials "may not be predictive of the response" in children in the New England Journal of Medicine? And infant monkeys given Singulair had to be euthanized because "infants may be more sensitive" FDA reviewers wrote?
Last month, the saga of Singulair mismarketing story continued when Fox TV reported that Merck's top selling allergy drug is suspected of producing aggression, hostility, irritability, anxiety, hallucinations and night-terrors in kids, symptoms that are being diagnosed as ADHD.
And that Singulair is being huckstered to parents by the trusted educational service Scholastic, Inc. and the American Academy of Pediatrics.
Eight-nine parents on the drug site askapatient.com report hyperactivity, tantrums, depression, crying, school trouble, facial tics and strange eye movements after their children, some as young as one, were put on Singulair. Similar reports appear on medications.com and parentsforsafety.org. Most symptoms subside when Singulair is stopped.
"Do NOT recommend this drug to other parents," writes one mother. "4 year olds that suddenly talk about killing themselves are influenced by a DRUG!!
"THE GOVERNMENT SHOULD BE ASHAMED OF THEMSELVES FOR APPROVING THIS!!!!" writes another mother, though the shame may well not stop there.
Martha Rosenberg frequently writes about the impact of the pharmaceutical, food and gun industries on public health. Her work has appeared in the Boston Globe, San Francisco Chronicle, Chicago Tribune and other outlets.